BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIFOCUS GUIDEWIRE

    MDR report key: 18265030 · Received December 5, 2023

    Report

    Report Number
    9681834-2023-00253
    Event Type
    Injury
    Date Received
    December 5, 2023
    Date of Event
    November 14, 2023
    Report Date
    December 5, 2023
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K863138
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: PATIENT IDENTIFIER: REQUESTED, NOT PROVIDED A2: AGE & DATE OF BIRTH: REQUESTED, NOT PROVIDED A3: PATIENT SEX: REQUESTED, NOT PROVIDED A4: WEIGHT: REQUESTED, NOT PROVIDED A5: ETHNICITY: REQUESTED, NOT PROVIDED A6: RACE: REQUESTED, NOT PROVIDED D4: LOT NUMBER: REQUESTED, UNKNOWN D4: EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER D4: UDI: N/A AS THIS PRODUCT CODE IS NOT EXPORTED TO THE US MARKET D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED G4: PMA/510(K): K926214, K923607 H4: DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, INVESTIGATION OF IT COULD NOT BE PERFORMED. SINCE THE INVOLVED LOT WAS UNKNOWN, THE MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS COULD NOT BE INVESTIGATED. REGARDING THE INVOLVED PRODUCT CODE, NO SIMILAR COMPLAINT ATTRIBUTABLE TO THE MANUFACTURING PROCESS WAS REPORTED IN THE PAST TWO YEARS. SINCE THE INVOLVED LOT WAS UNKNOWN, IT WAS NOT POSSIBLE TO INVESTIGATE THE MANUFACTURING RECORDS AND SHIPPING INSPECTION RECORDS. IN ADDITION, SINCE THE ACTUAL SAMPLE WAS NOT RETURNED AND INVESTIGATION OF IT COULD NOT BE PERFORMED, IT WAS NOT POSSIBLE TO CLARIFY THE CAUSE OF OCCURRENCE. RELEVANT INSTRUCTION FOR USE (IFU) REFERENCE: "IF ANY RESISTANCE IS FELT OR IF THE TIP'S BEHAVIOR AND/OR LOCATION SEEMS IMPROPER, STOP MANIPULATING THE GLIDEWIRE AND/OR THE CATHETER AND DETERMINE THE CAUSE BY FLUOROSCOPY. FAILURE TO EXERCISE PROPER CAUTION MAY RESULT IN BENDING, KINKING, SEPARATION OF THE GUIDE WIRE'S TIP, DAMAGE TO THE CATHETER, OR DAMAGE TO THE VESSEL." TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THERE WAS A FRACTURE INVOLVING THE RADIFOCUS GUIDEWIRE. NO RESIDUE REMAINED IN THE PATIENT (RETRIEVAL WAS COMPLETED). THE PROCEDURE OUTCOME WAS NOT REPORTED. THE FRACTURED PIECE WAS RETRIEVED. THE EVENT OCCURRED INTRA-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065215 RADIFOCUS GUIDEWIRE WIRE, GUIDE, CATHETER DQX TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention